Kornimate/medical-research-clean huggingface dataset:
influence of opioid analgesia on circulating tumor cells in laparoscopic colorectal cancer surgery

Conditions: Colorectal Cancer; Circulating Tumor Cell

Summary: to compare the effects of three types of perioperative analgesia on the number of circulating tumor cells following radical colorectal cancer surgery. to find correlations with other perioperative factors and clinical/pathological disease characteristics.


Eligibility criteria:
inclusion criteria: * patients undergoing open radical surgery for colorectal cancer * age over 18 years * signed informed consent exclusion criteria: * intolerance of the study drugs * history of crc surgery * neoadjuvant therapy * other malignancy not in permanent remission * chronic opioid medication or opioid administration within 7 days preoperatively * immunosuppressive or corticosteroid therapy * surgery within 30 days preoperatively (except minor) * chronic or acute infection

Keywords: perioperative analgesia colorectal cancer circulating tumor cell
evaluation of physical performance in old adults with sarcopenic obesity

Conditions: Obesity; Sarcopenia

Summary: the primary objectives of the present study are to estimate the sarcopenic proportion in a cohort of obese older subjects who have been hospitalized. the secondary objective is to individuate several clinical variables that differ between the sarcopenic obese patient and the not sarcopenic obese patient.

80 obese patients of both genders (bmi \> 35), with an age \> 60 years, hospitalized at the hospital san giuseppe, istituto auxologico italiano, irccs, piancavallo (vb) are selected. for each patient, the following information are collected at the time of admission: * anthropometric parameters (height, weight, bmi, waist and hip circumference); * body composition (free fat mass, fat mass), measured with impedance (bia) and dexa; * hand strength measured with the hand grip test; * explosive strength of lower limbs, measured with the stair climbing test; * senior fitness test (sft), a battery of tests useful to estimate the fitness level in the elderly. sft is a test that leads to measuring different physical parameters typical of daily activities: strength of upper and lower limbs, aerobic resistance, flexibility of lower and upper limbs, agility, and dynamic equilibrium. the measurements obtained make it possible to classify the skills as high function or low function. * physical performance test (ppt), which evaluates 7 physical capabilities areas of the subject to perform actions during daily life. the cut-off to determine the motor limitation condition is a score of ≤ 20 (out of 28 points). * questionnaire sf-12 (short form health survey), which leads to a multi-dimensional measuring of the life quality related to health. it is composed of 12 questions from which can be obtained two synthetic indices, one related to physical health and one related to mental health. * oswestry disability index questionnaire, elaborated to have information on how back problems, or leg problems, can influence physical abilities related to daily life. the presence of sarcopenia is identified based on the european working group on sarcopenia in older people (ewgsop2) (cruz-jentoft aj et al. 2019) definition. the physical performance parameters is evaluated according to the age, sex, obesity grade, and presence of sarcopenic obesity.

Eligibility criteria:
inclusion criteria: * obese patients (bmi \> 35), * both genders * age \> 60 years * hospitalization at san giuseppe hospital, istituto auxologico italiano, irccs, piancavallo (vb), italy for a multidisciplinary 3-week body weight reduction program exclusion criteria: * obese patients with bmi \< 35 * age \< 60 years

Keywords: aging obesity sarcopenia physical performance
25-hydroxyvitamin d pharmacokinetic study

Conditions: Vitamin D Deficiency; Fat Malabsorption

Summary: to evaluate the pharmacokinetic parameters of orally administered 25-hydroxyvitamin d3 \[25(oh)d3\] and vitamin d3 from the corresponding serum concentration-time curves in healthy adults and adults with a history of intestinal malabsorption.

patients with a history of intestinal malabsorption (n=10) and healthy volunteers (n=10); (of both sexes and all ethnicities) will be recruited in this randomized double-blind crossover study. all subjects will be prescreened for 25(oh)d levels to include subjects with 25(oh)d\<30 ng/ml. the subjects will be randomized to receive a single oral dose of 900 µg of either vitamin d3 or 25(oh)d3. blood samples will be taken at baseline and at 2,4,6,8,12 hours and days 1,2,3, 7 and 14. after a washout period of at least 14 days (2 weeks) the subjects will receive in a double blinded manner a single oral dose of 900 µg of either 25(oh)d3 or vitamin d3 (depending on which one they took in the randomization) any time after the washout. blood samples will be taken at baseline and at 2,4,6,8,12 hours and days 1,2,3,7, 14. serum levels of calcium, phosphorus, albumin, creatinine, intact parathyroid hormone (ipth) will be obtained at baseline and at day 14 (or within a reasonable time if unable to come in on the exact day). vitamin d and 25(oh)d will be determined on all the blood samples collected at the various times.

Eligibility criteria:
inclusion criteria: * adult male or female with history of intestinal fat-malabsorption with confirmed diagnosis * taking vitamin d (ergocalciferol or cholecalciferol). subjects taking vitamin d supplement of more than 2000 ius (50 micrograms)/day) that may interfere with study endpoints must be willing and able to discontinue use of these supplements for the duration of the study and allow for at least a 14-day washout prior to prescreening and enrollment. * women of child bearing potential must be on birth control and not pregnant based on a negative pregnancy test at baseline for each of the 2 pharmacokinetic studies. * serum total 25(oh)d \< 30 ng/ml exclusion criteria: * unwilling to discontinue use of supplemental dose of vitamin d2 (ergocalciferol) or vitamin d3 (cholecalciferol) daily equivalent (2,000 iu/50 μg) 1 week or less prior to randomization and during the study * on medications that can affect vitamin d metabolism including steroids such as prednisone, anti-seizure medications and medications to treat hiv. * tanning in a tanning bed at least one week before the study and throughout the duration of this study. * anyone anticipating going on holiday (where exposure to sun is imminent) 1 week before or during the entire study. * participation in the study or any reason which, in the opinion of the investigator makes adherence to a treatment or follow-up schedule unlikely * history of elevated serum calcium * chronic hepatic or renal failure * subjects with a history of an adverse reaction to orally administered vitamin d. * inability to give informed consent

Keywords: calcifediol (25(oh)d) calciferol (vitamin d)
folfox6 plus sir-spheres microspheres plus avastin in patients with nonresectable liver metastases from colorectal carcinoma

Conditions: Colorectal Carcinoma; Liver Metastases

Summary: this pilot study will evaluate the safety and effectiveness of chemo-radiotherapy comprising a regimen of folfox6 chemotherapy plus sir-spheres yttrium-90 microspheres (chemo-radiotherapy, also known as "chemo-sirt"), in combination with the biologic therapy bevacizumab (avastin), for the first-line treatment of patients with liver metastases from colorectal carcinoma in whom surgical resection is not feasible.


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the colon or rectum. * unequivocal and measurable ct evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent. * ecog performance status 0 - 1. * adequate hematological, renal and hepatic function. exclusion criteria: * evidence of ascites, cirrhosis, portal hypertension, main portal vein tumor involvement or thrombosis as determined by clinical or radiologic assessment. * any extra-hepatic metastases other than metastases in the lungs and/or bones and/or abdominal or hilar lymph nodes. central nervous system (cns) metastases are not allowed. * previous radiotherapy delivered to the upper abdomen. * peripheral neuropathy \> grade 1 (nci-ctcv3).

Keywords: colon cancer colorectal cancer liver metastases sir-spheres microspheres yttrium-90 folfox bevacizumab chemo-radiation
the impact of covid-19 pandemic on the incidence and outcome of complicated appendicitis

Conditions: Covid19; Appendicitis

Summary: during the covid-19 pandemic, we noticed a rise in complicated appendicitis cases presenting to our medical center. we collected objective data on all patients admitted to the surgical department with appendicitis during february 2020 - march 2020 compared to the same 2 month period in 2019, to understand the pandemic's affect on the rate of complications of acute appendicitis.

coronavirus pandemic (covid-19) first broke out in wuhan and hubei china during december 2019. on 30 january, who declared it a public health emergency of international concern (pheic) . currently, the number of cases worldwide stands stands at more than 76 million confirmed cases according to the world health organization (who) records. first documented case in israel was reported on 21st of february 2020. during the months of february and april, due to continued rise in confirmed cases, rigid "stay at home" restrictions were issued. these restrictions have had a significant effect on daily life. under these new "stay at home" policies, many aspects of everyday life were greatly diminished and restricted under threat of heavy fines. this effect also extends to reduction in healthcare seeking. decline in emergency department (ed) visits was reported. a drop in routine cancer screening appointments was reported. delayed healthcare seeking also had an affect on the severity of various medical conditions on presentation. fear of the covid-19 pandemic may have resulted in delayed diagnosis, and therefore higher complication rates in common medical conditions. acute appendicitis (aa) is among the most common causes of lower abdominal pain leading patients to attend the emergency department. as such, aa could serve as a good indicator for the possible effect that the fear of the covid-19 pandemic had on patients tendency for late diagnosis and complication rate. gomes laparoscopic grading system of aa, classifies appendicitis into five laparoscopic grades according to gross morphologic findings during surgical laparoscopy. grades 1 and 2 regarded as non-complicated appendicitis, while grades 3, 4 and 5 regarded as complicated appendicitis. following the restrictions imposed during the covid-19 pandemic, we noticed a rise in complicated appendicitis cases presenting to our medical center. we collected objective data on all patients admitted to the surgical department with appendicitis during february 2020 - march 2020 compared to the same 2 month period in 2019. data such as the time period from onset of symptoms to presenting to the ed, inflammatory markers, complicated appendicitis (if any), type of complication, post operative complications. we aim to assess whether the "stay at home" restrictions had any adverse effects on severity or outcomes of aa.

Eligibility criteria:
inclusion criteria: * appendicitis exclusion criteria: * any other diagnosis

Keywords: covid19 appendicitis laparoscopy
effect of a mobile health intervention on treatment adherence

Conditions: HIV I Infection

Summary: this is a randomized clinical trial across the whole of the patients who attend the hiv unit of the hospital civil viejo, a sample calculated in 43 patients for each group (intervention and control). patients who have hiv infection and are starting antiretroviral treatment (art), who are between 18 and 50 years old and have a mobile device, will be included in the study. the messages will consist of medical appointment reminders and adherence and motivational messages for a period of six months.


Eligibility criteria:
inclusion criteria: * recently diagnosed with hiv infection . starting with antiretroviral therapy and haven't taken art before * patients with the status of "lost to follow up" who return to re-initiate art exclusion criteria: * patients who are participating in other study * patients above 18 years old * patients who does not have signal phone at their residency * those who refuses to participate in the study

Keywords: electronic health adherence
effects of open-label vs double-blind treatment in ibs

Conditions: Irritable Bowel Syndrome; Placebo Effect; Placebos; Peppermint Oil

Summary: the purpose of this study is to investigate placebo effects and peppermint oil in irritable bowel syndrome.


Eligibility criteria:
inclusion criteria: * meet rome iv diagnostic criteria for ibs
comparative effects of neural mobilization and muscle energy technique in sciatic patients

Conditions: Acute Sciatica; Pain

Summary: in this study, investigator will see the effects of neural mobilization in comparison to the muscle energy technique in the patients suffering from sciatica. impact of the these two interventional techniques , there out come measures i.e pain, range of motion and functional disability.

this study is aimed in comparison among two interventional techniques i.e neural mobilization and muscle energy technique patients with sciatica. this study will be a randomized controlled trial with double blinded protocol, patients will be randomly allocated in to the two groups. one is the neural mobilization technique group and other is the muscle energy technique group. both of the groups have the conventional physical therapy in addition to these two interventions. data will be collect from the patients.30 minutes session twice a week will be given to the patients in each group. assessment will be done by using visual analog scale, goniometer, modified oswestry disability index. data will be entered and analyzed by using spss.

Eligibility criteria:
inclusion criteria: * • both genders * between the ages group of 35-60 years * patients with diagnosis of sciatica. * straight leg raise\< 45°. * having symptoms from past one month. exclusion criteria: * inflammatory or other specific disorders of the spine such as ankylosing spondylitis, vertebral collapse, rheumatoid arthritis, stenosis, spondylolysthesis and osteoporosis. * history of any previous spinal surgical intervention * symptomatic bilateral radiculopathy * presence of any of red flags related to spinal column * history of involvement in any exercise program for lower extremity in recent time

Keywords: neural mobilization muscle energy technique sciatica
test of trans-cranial magnetic stimulation (tms) intervention on unilateral neglect

Conditions: Stroke

Summary: problems in attention can affect around 40% of stroke survivors and are associated with poor recovery of function. this project will provide the largest scale and most detailed examination to date of whether problems in attention after stroke can be remediated through direct brain stimulation. in part 1 of the project the investigators will use two forms of direct brain stimulation (neural inhibition) to try and balance activity across the two sides of the brain following a stroke to one side. the investigators will assess whether each form of stimulation leads to an improvement in attentional functions, as well as to wider improvements in other cognitive abilities and to activities of everyday living. performance will be tested immediately post remediation and on longer-term follow-up, and performance of the two intervention groups will be assessed against data the investigators have collected from a large-scale screen of cognitive impairments and recovery of function under standard treatment conditions. in part 2 of the project the investigators will take the most promising intervention from part 1 and the investigators will use magnetic resonance imaging (mri) to determine the brain changes that are linked to the recovery of attentional functions. the investigators will test whether recovery is linked to a change in the balance of activation within the two hemispheres of the brain, and whether there are associated structural changes in cortical tissue and fibre tracts. the project will evaluate whether neural inhibition can improve attentional functions in particular, and cognitive abilities and everyday activities more generally, in stroke survivors. it will also provide novel information on how recovery of function comes about within the brain.


Eligibility criteria:
inclusion criteria: * presence of left unilateral neglect after right hemisphere stroke exclusion criteria: * presence of epilepsy/family history of epilepsy * insufficient comprehension to follow instructions

Keywords: unilateral neglect tms intervention
effect of dapagliflozin administration on metabolic syndrome, insulin sensitivity, and insulin secretion

Conditions: Metabolic Syndrome X

Summary: the metabolic syndrome is a high prevalence disease worldwide. about a quarter of the adult population suffers the disease. dapagliflozin is an inhibitor of the sodium-glucose co-transporter sglt2 in the kidney and is a novel treatment for diabetes type 2. some studies indicate that sglt2 inhibitors have benefits on blood pressure, triglycerides levels and help to raise the levels of high density lipoproteins cholesterol (c-hdl). the aim of this study is to evaluate the effect of dapagliflozin on metabolic syndrome, insulin sensitivity and insulin secretion. the investigators hypothesis is that the administration of dapagliflozin modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

a randomized, double-blind, placebo-controlled clinical trial its going to carry out in 24 patients with a diagnosis of metabolic syndrome in accordance with the international diabetes federation (idf). waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric are going to be load after a 75 g of dextrose load. 12 patients will receive forxiga (dapagliflozin), 10 mg, one per day before breakfast during 3 months. the remaining 12 patients will receive placebo at the same dose. there will be calculated area under the curve of glucose and insulin, total insulin secretion (insulinogenic index), first-phase of insulin secretion (stumvoll index) and insulin sensitivity (matsuda index). this protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers. results will be presented as mean and standard deviation. intra and inter group differences are going to be tested using the wilcoxon signed-rank and mann-whitney u-test respectively; p≤0.05 it's going to be considered significant.

Eligibility criteria:
inclusion criteria: * patients both sexes * age between 30 and 60 years * metabolic syndrome according to the idf criteria * waist circumference * man ≥90 cm * woman ≥80 cm * and two of the following criteria * high density lipoprotein * man ≤40 mg/dl * woman ≤50 mg/dl * fasting glucose ≥100 mg/dl * triglycerides ≥150 mg/dl * blood pressure ≥130/85 mmhg * informed consent signed exclusion criteria: * women with confirmed or suspected pregnancy * women under lactation and/or puerperium * hypersensibility to sglt2 inhibitors * physical impossibility for taking pills * known uncontrolled renal, hepatic, heart or thyroid diseased * previous treatment for the metabolic syndrome components * body mass index ≥39.9 kg/m2 * fasting glucose ≥126 mg/dl * triglycerides ≥500 mg/dl * total cholesterol ≥240 mg/dl * low density lipoprotein (c-ldl) ≥190 mg/dl * blood pressure ≥140/90 mmhg

Keywords: metabolic syndrome forxiga dapagliflozin insulin secretion insulin sensitivity
characterization of tissular t follicular helper cells in igg4-rd

Conditions: Disease Immunoglobulin G4

Summary: igg4-related disease (igg4-rd) is a recently identified rare disease characterized by inflammatory lesions with polyclonal lymphoplasmocytic infiltrate, with igg4+ plasma cells predominance, and fibrosis in involved tissues. despite a preferential involvement of exocrine organs, virtually all tissues can be affected by the disease. corticosteroids are usually effective in this indication, but with poor tolerance and a high risk of relapse after decrease or withdrawal of this treatment. in this context, identification of new therapeutic targets is a major concern for these patients. physiopathology of igg4-rd remains actually unknown. in previous studies, it has been shown that t follicular helper (tfh) cells are expanded in the blood of these patients. tfh cells have an important role in the formation of germinal centers (gcs), and ectopic gcs have been found in tissues of patients with igg4-rd. tfh cells have a major role in proliferation and differentiation of b cell compartment. in this context, this population could have an important contribution in the pathophysiology of igg4-rd and could represent a therapeutic target in this disease. tifolh4 study intend to analyze tissue tfh cells in patients with igg4-rd at diagnosis. this study is an exploratory prospective multicentric study. thirty patients with a suspected diagnosis of igg4-rd, because of 1 or more suggestive organ involved, will be included in the study. a 50 ml blood sample and a biopsy, obtained in the same time of the diagnostic biopsy sample, will be obtained in this study. the results obtained in patients with a confirmed diagnosis of igg4-rd (" igg4-rd group ") will be compared to results of patients with another diagnosis (" control group "). main objective of the study is to show by confocal microscopy an expansion of the number of tfh cells (cd3+cd4+pd1+ cells) in tissue of igg4-rd patients compared to controls. secondary objectives include : tissue analysis of tfh subsets (tfh1, tfh2 and tfh17) ; tissue analysis of b regulatory cells, t regulatory cells, and t helper cells (th1, th2, th17); correlation between tissue and circulating biomarkers; tissue proteomic analysis; and functional analysis of circulating tfh cells after sorting of these cells and co-culture tests with autologous naive b cells. all these results will be compared between the " igg4-rd group " and the " control group ". this study should clarify the role of these tfh populations in igg4-rd, identify diagnostic tissue and blood biomarkers, and identify therapeutic targets in these patients.


Eligibility criteria:
inclusion criteria: * patient with a diagnosis of disease associated with igg4 * patient signed a consent * patient affiliated to the social security scheme exclusion criteria: * patients with a corticosteroid therapy current or less than 3 months. * patients with an immunosuppressive treatment or being less than 3 months * patients with a biotherapy treatment by ongoing or less 6 months